The Effect of Recurrent Application of Liquid Platelet-rich Fibrin in the Extraction Socket on the Hard and Soft Tissues. A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ridge dimensions
研究概览
简要总结
Procedure: Tooth is extracted, then A-PRF+ is placed inside the socket. After that the ridge dimensions is asses clinically at the baseline) in addition to clinical assessment of the gingival biotype at the baseline.
Then patients will be divided into 2 groups:
Group 1: 50% of patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Group 2: 50% of patients without recurrent (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) & (Ridge dimensions) in order to assess the role of recurrent application of Liquid-PRF on these parameters.
详细描述
In this study, we will select 20 patients who need a simple tooth extraction, then determine the gingival biotype, take a blood sample to prepare A-PRF+ (centrifugation of the patient's blood for 8 min at 1300 rpm using red caps tubes), then do the extraction. After that, A-PRF+ is prepared and inserted into the extraction socket, and sutured using horizontal mattress suturing technique.
After the clinical assessment of the ridge dimensions at the baseline
Then patients will be divided into 2 groups:
Group 1: 10 patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Liquid-PRF preparation: Centrifugation of the patient's blood for 8 min at 2500 rpm using white caps tubes.
Group 2: 10 patients without recurrent application of Liquid-PRF (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) & (Ridge dimensions) in order to evaluate the effect of recurrent application of Liquid-PRF on these parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women over 18 years of age
- •Indication of a simple extraction (Non-molar tooth)
- •Delivery of signed informed consent
- •Need delayed implant placement in the place of extraction
排除标准
- •Need for multiple extractions
- •Presence of severe swelling prior to surgery in the extraction area
- •Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs
- •Presence of hematologic disease
- •Previous radiation, chemotherapy, or immunosuppressive treatments
- •Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy
结局指标
主要结局
Ridge dimensions
时间窗: 3 months
assessment of ridge dimensions 3 months after intervention for both groups. At the baseline it was assessed clinically. After 3 months, the flap was released and the ridge width and height were assessed clinically.
Gingival biotype
时间窗: 3 months
assessment of gingival biotype 3 months after intervention according to gingival thickness (using periodontal probe: if \<1 mm = Thin, while if \>1 =Thick).
次要结局
未报告次要终点
研究者
Cezar Edward Lahham
Principal Investigator
Arab American University (Palestine)